Higher Ropeginterferon Alfa-2b Dose Regimen Demo... - MPN Voice

MPN Voice

10,887 members15,202 posts

Higher Ropeginterferon Alfa-2b Dose Regimen Demonstrates Long-Term Benefits in Polycythemia Vera

Manouche profile image
3 Replies

   “Our results suggest that a higher initiating-dose regimen, with the flexibility of dose schedule adjustment from biweekly to monthly, i.e., once every 3-5 weeks, after the CHR is stabilized with 1 year of ropeg treatment is associated with a high chance of neoplastic cell clearance and robust clinical benefits,” the researchers concluded.

“Despite the CHR rate reaching a plateau, the JAK2V617F VAF or allele burden continued to decline, indicating that the treatment continuously eradicated the neoplastic clones,” the researchers wrote in their report.

hematologyadvisor.com/news/...

Written by
Manouche profile image
Manouche
To view profiles and participate in discussions please or .
Read more about...
3 Replies
Ovidess profile image
Ovidess

The complete molecular remission at 2 years sounds great. But I never read about what doctors say to do then. Can one have a nice long drug vacation with only lab checkups? Or go on to 5 years of Besremi/Peg as used to be the guideline?

hunter5582 profile image
hunter5582

Interesting finding; however, not all can tolerate such a high dose of Besremi. It will be interesting to see how the longer term low dose strategy works in comparison.

EPguy profile image
EPguy

They report CMR of 25% at two years. This is better than the 6 year Ropeg result of 20.7%, ( <1% being the reference there) but the smaller sample size may be a factor, they don't give a p value. These may be the pts most likely to have durable non-rising MR after year 5.

This is a good reality check that 75-80% of us on IFN (and analogous findings for Rux) will not get to CMR in these time frames, if the trial results carry over. But of course hoping we can do better.

This report follows a pattern I see for all our drugs:

"77.3% of patients achieving CHR by 15 months, 84.1% at 18 months, 81.8% at 21 months, and 75% at 24 months."

So % of pts with CHR start to decline at 18months.

"93.9% of patients ... achieved CHR at least once during 24 months " this also implying that CHR was fleeting for some.

I understand it as CHR for a signif set is not durable. HU and Rux have similar reports. But I'm not sure if we see this on the forum for our various meds.

--

The 3 year ProudPV Ropeg trial also used a very high dose at least thru year 1, this plot shows the dosing. Only the titration was slower,

Fig 7 of:

accessdata.fda.gov/drugsatf...

As Hunter says, this dose likely wouldn't work for some pts as we've read here many members here cannot tolerate such doses. I suspect I would not have survived such dosing.

ropeg dosing

Not what you're looking for?

You may also like...

Effective Management of Polycythemia Vera With Ropeginterferon Alfa-2b Treatment

Discussion; The results in our study demonstrate that the new dosing regimen of 250-350-500 µg of...
Manouche profile image

FDA Rejects Ropeginterferon alfa-2b for Polycythemia Vera

« The drug development process is not always easy or quick. It consists of drug discovery,...
Manouche profile image

FDA Approves Ropeginterferon Alfa-2b-njft for Polycythemia Vera

The FDA has approved ropeginterferon alfa-2b-njft (Besremi) for use as a treatment in patients...
JT_Marlin profile image

Ropeginterferon Alfa-2b listed as Preferred Treatment in Polycythemia Vera

The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology have been...
Manouche profile image

FDA Issues Complete Response Letter for Ropeginterferon Alfa-2b for Polycythemia Vera

« The FDA has issued a complete response letter regarding the biologics license application for...
Manouche profile image